Z-0350-2019Class II
Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80
Cook Medical LLC / initiated 2018-09-25 / Terminated / root cause: labeling and UDI
Cook Medical Incorporated began a recall of Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of... on . FDA classified it as Class II and gives the reason as "The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0350-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Cook Medical LLC
- Product
- Zilver 635 Biliary Stent 5mm x 80mm, Catalog Number: ZIB6-80-5.0-80 Product Usage: The Zilver 518 and 635 Biliary Stents are intended for palliation of malignant neoplasms in the biliary tree.
- Product code
- FGE Stents, Drains And Dilators For The Biliary Ducts
- Reason for recall
- The instruction for use detail, with respect to removal of the delivery system as part of Deployment of the stent is incorrect and the IFU is being corrected to amend the instruction for use detail.
- Root cause tag
- labeling and UDI
- FDA root cause
- Under Investigation by firm
- Action
- Urgent Medical Device Correction notification letters dated 9/25/18 were distributed to customers. The letter identified affected product, problem and actions to be taken. Urgent Medical Device Correction notification letters dated 9/25/18 were distributed to customers. Customers were instructed to: 1. Examine your inventory immediately to determine if you have affected product(s). 2. Read the notice carefully and communicate the correction to users. 3. Maintain a copy of this notice for your own records. 4. Ensure users are aware of the IFU modifications. 5. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter and return it via fax (812.339.7316) or email ([email protected]). Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return it. 6. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30 am and 5:00 pm (Eastern Time) or by email to [email protected]. For questions contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235.
- Quantity in commerce
- 9834 total
- Distribution
- US Nationwide Distribution in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, and Puerto Rico.
- Product codes and lots
- GPN: G36015
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0314-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0315-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0316-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0317-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0318-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0319-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0320-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0321-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0322-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0323-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0324-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0325-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0326-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0327-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0328-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0329-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0330-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0331-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0332-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0333-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0334-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0335-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0336-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0337-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0338-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0339-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0340-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0341-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0342-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0343-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0344-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0345-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0346-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0347-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0348-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0349-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0350-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0351-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0352-2019 | Class II | Terminated | Voluntary: Firm initiated |
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